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Online Physical Activity Program for Multiple Sclerosis (BIPAMS-Cog Trial)

N/A

Recruiting

Led By Robert W Motl, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate without assistance (self-report and PDDS)

Between 18+ years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in fatigue from baseline, 6-months, and 12-months

Summary

This trial will test if an Internet-delivered physical activity intervention can improve cognitive processing speed, learning and memory, symptoms, and quality of life in MS patients.

Who is the study for?

This trial is for adults in the U.S. with Multiple Sclerosis who are physically inactive, can walk without help, and have had no MS relapses in the last 30 days. Participants must speak English, have internet access, be willing to answer questionnaires, wear an accelerometer device, and accept random assignment to one of two intervention groups.

What is being tested?

The study tests two online interventions aimed at improving cognitive processing speed (CPS) in people with mild MS-related walking difficulties: a physical activity program called BIPAMS and a wellness education program known as WellMS. The main goal is to see if these programs can also improve memory, reduce symptoms like fatigue and pain, and enhance quality of life.

What are the potential side effects?

Since this trial involves lifestyle interventions focused on physical activity and wellness education delivered via the Internet rather than medication or invasive procedures, side effects may include typical exercise-related discomforts such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk by myself without help.

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I am 18 years old or older.

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I have been diagnosed with multiple sclerosis (MS).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in fatigue from baseline, 6-months, and 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in fatigue from baseline, 6-months, and 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in fatigue from baseline, 6-months, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition

Secondary study objectives

Anxiety

Depressive Symptoms

Fatigue Impact

+2 more

Other study objectives

Accelerometry

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Behavioral Intervention for Physical Activity in MS (BIPAMS)Experimental Treatment1 Intervention

The current behavioral intervention consists of two primary components; an internet website and oneonone video chats with a behavioral coach.The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory.Each course consists of an introduction,the primary content,and a take home message.The interactive courses include embedded,supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps,and these steps will be entered into the website so progress can be monitored.The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries.The chats are conducted facetoface through an online videoconferencing platform.The chats occur 7 times during the first 2 months,4 times during the second 2 months,and twice during the final 2 months of the intervention.

Group II: Wellness for MS (WellMS)Placebo Group1 Intervention

Provides an internet website and oneonone video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity.The materials are transformations of brochures provided by the National MS Society,including Gait or Walking Problems:The Basic Facts;MS and Your Emotions;Pain:The Basic Facts; Solving Cognitive Problems;Taming Stress in MS;Food for Thought:MS and Nutrition;and Vitamins,Minerals,and Herbs:An Introduction.The delivery of the internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition,and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention for Physical Activity in MS (BIPAMS)

2020

N/A

~30

0 / 3Eligibility criteria met